Young Graeme P, Senore Carlo, Mandel Jack S, Allison James E, Atkin Wendy S, Benamouzig Robert, Bossuyt Patrick M M, Silva Mahinda De, Guittet Lydia, Halloran Stephen P, Haug Ulrike, Hoff Geir, Itzkowitz Steven H, Leja Marcis, Levin Bernard, Meijer Gerrit A, O'Morain Colm A, Parry Susan, Rabeneck Linda, Rozen Paul, Saito Hiroshi, Schoen Robert E, Seaman Helen E, Steele Robert J C, Sung Joseph J Y, Winawer Sidney J
Flinders Center for Innovation in Cancer, Flinders University, Adelaide, South Australia, Australia.
Reference Center for Epidemiology and Cancer Prevention, Piedmont Regional Center for Preventive Oncology, City Health and Science University Hospital of Turin, Turin, Italy.
Cancer. 2016 Mar 15;122(6):826-39. doi: 10.1002/cncr.29865. Epub 2016 Feb 1.
New screening tests for colorectal cancer continue to emerge, but the evidence needed to justify their adoption in screening programs remains uncertain.
A review of the literature and a consensus approach by experts was undertaken to provide practical guidance on how to compare new screening tests with proven screening tests.
Findings and recommendations from the review included the following: Adoption of a new screening test requires evidence of effectiveness relative to a proven comparator test. Clinical accuracy supported by programmatic population evaluation in the screening context on an intention-to-screen basis, including acceptability, is essential. Cancer-specific mortality is not essential as an endpoint provided that the mortality benefit of the comparator has been demonstrated and that the biologic basis of detection is similar. Effectiveness of the guaiac-based fecal occult blood test provides the minimum standard to be achieved by a new test. A 4-phase evaluation is recommended. An initial retrospective evaluation in cancer cases and controls (Phase 1) is followed by a prospective evaluation of performance across the continuum of neoplastic lesions (Phase 2). Phase 3 follows the demonstration of adequate accuracy in these 2 prescreening phases and addresses programmatic outcomes at 1 screening round on an intention-to-screen basis. Phase 4 involves more comprehensive evaluation of ongoing screening over multiple rounds. Key information is provided from the following parameters: the test positivity rate in a screening population, the true-positive and false-positive rates, and the number needed to colonoscope to detect a target lesion.
New screening tests can be evaluated efficiently by this stepwise comparative approach.
用于结直肠癌的新型筛查测试不断涌现，但在筛查项目中采用这些测试所需的证据仍不明确。
对文献进行综述，并采用专家共识方法，为如何将新型筛查测试与已证实的筛查测试进行比较提供实用指导。
综述的结果和建议包括以下内容：采用新型筛查测试需要有相对于已证实的对照测试的有效性证据。在筛查背景下基于筛查意向的项目人群评估所支持的临床准确性，包括可接受性，至关重要。只要对照测试的死亡率益处已得到证实且检测的生物学基础相似，癌症特异性死亡率作为终点并非必不可少。基于愈创木脂的粪便潜血试验的有效性提供了新测试应达到的最低标准。建议进行四阶段评估。首先在癌症病例和对照中进行回顾性评估（第1阶段），随后对肿瘤病变连续体的性能进行前瞻性评估（第2阶段）。第3阶段在这两个预筛查阶段证明具有足够准确性之后进行，并在一轮筛查中基于筛查意向解决项目结果问题。第4阶段涉及对多轮持续筛查进行更全面的评估。关键信息由以下参数提供：筛查人群中的测试阳性率、真阳性率和假阳性率，以及检测目标病变所需的结肠镜检查人数。
通过这种逐步比较方法可以有效地评估新型筛查测试。
